View clinical trials related to Breast Cancer.
Filter by:This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy, versus 6 cycles of Docetaxel- Cyclophosphamide (DC)-chemotherapy, and to compare the disease free survival in patients with BMI of 24 - 40 kg/m² after randomisation with versus without the lifestyle intervention. Patients will be required to have histopathological proof of a HER2/neu negative tumor and: axillary lymph node metastases (pN1-3) or high risk node negative, defined as: 'pT ≥2 or histopathological grade 3, or age ≤35 or negative hormone receptor status, but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study.
The purpose of this study is to evaluate the pathological CR rate in breast and lymph nodes of a novel neoadjuvant regimen for invasive breast carcinoma.
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib for HER2-positive metastatic breast cancer (MBC). Patients were treated until disease progression, unmanageable toxicity, or study termination. Once disease progression was reported, all patients were followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.
The purpose of this study is to analyze gene expression signature and immunohistochemical markers associated with clinical and pathological response to neoadjuvant chemotherapy in locally advanced breast cancer.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer. PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.
This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
We hypothesize that Simvastatin administration would result in selective killing of the basal subtype of breast cancer, in particular, CD44+/CD24- breast cancer cells in primary tumor. We further hypothesize that tumor genomic changes would correlate with tumor response to Simvastatin. We are also looking to correlate Simvastatin biological effects with the expression pattern of initial status of primary tumor. In addition, we hypothesize that Simvastatin-induced tumor gene expression changes may correlate with tumor and plasma proteomics, peripheral blood mononuclear cell gene expression changes, and pharmacogenetics, and that these analyses may further refine the selection of patients most likely to benefit from Simvastatin.
This is an adjuvant, open, prospective, randomized study to compare: A. Individually tailored and two weekly dosed epirubicin + cyclophosphamide followed by a three weeks break followed by biweekly and tailored docetaxel (dtEC→dtT) given every second week, to B. Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by fixed dosed and three weekly docetaxel (FEC→T). Patients with primary node-positive or high risk lymph node negative breast cancer will be eligible for the study. The primary objective of the phase 3 study is to compare breast cancer relapse-free survival (BCRFS) between the dtEC→dtT and FE100C→T. To detect a five-year BCRFS difference of 0.710 to 0.790 about 1000 patients per arm will be needed. They will be recruited during four years and followed another two years for breast cancer events. Secondary objectives are to compare 1. Distant disease-free survival (DDFS) 2. Event-free survival and 3. Overall survival 4. Health-related quality of life and toxicity analyses according to CTC 5. Outcome in relation to tumour biological factors and polymorphism patterns 1. RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm 2. RFS with receptor positive disease (analyzed in the local laboratories as described in the CRFs and also analyzed as continuous variables) in the comparison between the A- and B- arms. 3. RFS with high and low proliferation, respectively, (analyzed in the local laboratories as described in the CRFs and also analyzed as a continuous variable, or centrally analyzed), in the comparison between the A- and B-arms. 4. RFS in relation to HER-2/neu status (analyzed in the local laboratories as described in the CRFs) in the primary cancers in the comparison between the A- and B-arms and analyzed whether trastuzumab was given in sequence or concurrently. 5. RFS analyzed in relation to other molecular markers (e.g. gene expression profiling/ sequencing) in the primary cancers and SNPs signatures in normal DNA (related to toxicities for EC/FEC and docetaxel components, respectively, and given dose levels and outcome in relation to these factors and in relation QoL) to outcome per arm. 6. RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein in the comparison between the A- and B-arms. Tumour tissue will be obtained and stored for studies of prognostication and therapy prediction. Last patient randomized was September 2011.
This is a randomized, Phase III, open-label, multicenter study.
The purpose of this study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast prior to surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and bevacizumab before surgery may allow for lesser amount of breast tissue to be removed. To be able to predict in the future which patients are more likely to get pCR to this drug combination, specialized tests on tumor tissue will be performed.